The Role of Oxytocin & Interoception in Functional Neurological Disorder

Status Recruiting

Clinical Trial Summary

The main goal of this project is to better understand the role of oxytocin and Interoception in FND. More specifically oxytocin's association with precision weighing, prediction errors and priors in the interoceptive domains will be investigated. To this end, several methods will be employed: analysis of interoceptive accuracy and sensibility (interoceptive tasks and questionnaires), biomarkers of oxytocin (peripheral, endogenous oxytocin), genetic oxytocin markers (such as allele-frequency in the oxytonergic receptor gene), epigenetics (methylation rates of genes related to oxytocin), neuroactivity (EEG).

Clinical Trial Description

The primary objective is to explore interoceptive processing during a behavioural (interoceptive) tasks and its association to the oxytocin (OT) system in patients affected by a functional neurological disorder (FND), in comparison to healthy controls (HC). Concerning interoception, as primary outcome, it is hypothesized that: A) FND patients are less interoceptive (judged by objectively measured accuracy) compared to HC in the interoceptive tasks. Concerning OT, as primary outcome, it is hypothesized that: B) The OT level is correlated with interoception tasks; specifically the adaption of precision weighting The secondary objectives are to: - Explore the validity and reliability of different interoceptive tasks (e.g. respiratory, cardiovascular, emotional tasks) - Explore neuronal regions associated with interoceptive processing and interoceptive accuracy in FND compared to HC - Investigate whether FND patients have a higher interoception trait-prediction error (discrepancy between subjective and objective interoception scores) and whether this correlates with their symptom severity - Explore the association of the breathing cycle and the voluntary initiation of mental or motor actions, and its readiness potential - Explore peripheral biomarkers (e.g. salivary OT) in FND patients, compared to HC - Explore the differences in (epi)genetic profile associated with the OT-system in FND compared to HC - Investigate the association of the OT-system and traumatic childhood experience, attachment styles and sexual functioning in patients of FND compared to HC ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06084325
Study type	Observational
Source	University of Fribourg
Contact	Selma Aybek, Prof.
Phone	+41 26 306 38 02
Email	selma.aybek@unifr.ch
Status	Recruiting
Phase
Start date	October 5, 2023
Completion date	December 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Role of Oxytocin and Interoception in Functional Neurological Disorder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms